The present invention relates to an adapter for use with angioplasty catheters supplying fluid communication and or multiple guide wire introduction that has a hemostasis capability.
In an angioplasty procedure, an accepted and well known medical practice, a catheter is placed into the vascular system of the patient, by first inserting a needle percutaneously into a blood vessel, and then inserting a wire through the needle lumen into the blood vessel, the needle is then removed, a sheath is inserted and the guide catheter is put in place. A guide catheter has a hub at its proximal end from which extends an elongated tubular portion that is open at its distal end. The guide wire is maneuvered and steered through the vascular system until its distal end extends past the area to be treated. With the guide catheter and wire in place, the balloon catheter is threaded through the lumen of the guide catheter. It exits the distal end of the guide catheter at a point approaching the area to be treated. The un-inflated balloon portion of the catheter is located within the artery such that it crosses the stenosis or reduced area. Pressurized inflation fluid is delivered to the inflatable balloon through a lumen formed in the catheter to thus dilate the restricted area. The inflation fluid is generally a liquid and is applied at relatively high pressures. As the balloon is inflated it expands and forces open the stenoses or reduced area of the artery.
Situations are occasionally encountered where it is desirable to utilize more than one dilation catheter and guide wire or more than one guide wire at the same time. An example of such a situation is when there are two or more lesions and it is desired to locate a dilation catheter adjacent to each lesion. In such a situation it may be desirable to dilate the lesions simultaneously thus requiring independent lumens for inflating each balloon. Another example of a situation in which multiple catheters and/or guide wires are desirable is in the situation where the lesion to be treated is close to a branch in the vessel and there is a possibility that dilation of the lesion could cause closure in the adjacent branch. In this situation a guide wire may be placed in the branch not being treated to facilitate getting a catheter to that branch quickly if the need occurs. In any situation in which multiple catheters and/or guide wires are used there are multiple elongated members extending through the vascular system making it even more important that each elongated member is unconstrained and undamaged such that it can be independently manipulated and positioned. The conventional Y-adapter has a main passageway and a branch passageway that joins the main passageway at an acute angle. When a catheter or guide wire is inserted through the branch passageway its first obstacle that must be negotiate is the angle between the main and branch passageways. The lumens forming these passageways are generally straight and intersect at a sharp angle. When a catheter is negotiated through the passageway intersection, it must be forced causing a curved deformation along the catheter shaft. In conventional Y-adapters the catheter is constrained by the internal surfaces of the passageways to a radius of approximately three-quarters of an inch or less. The elastic material from which the catheter is formed resist being bent around such a small radius. The resistance to being bent causes the catheter to be pressed against the internal surface of the passageways. As a result when the catheter is manipulated, twisted, pushed and pulled in an attempt to properly locate its distal end, its movement through the intersection is constrained and the rotational response is compromised. When the catheter is twisted or torqued it tends to wind up, with little or no immediate corresponding movement at the distal end. Then when the torque in the catheter reaches a certain level, it releases and unwinds or whips wildly. When this sudden release occurs the catheter is wildly and violently unwound and is whipped against the lumen walls and against the walls of the vascular system to which it is exposed.
It is a primary objective of the present invention to provide a Y-adapter that can receive a catheter or guide wire through its branch passageway that will merge smoothly into the main passageway and will accommodate the unincumbered manipulation of the catheter or guide wire.
Another objective of the present invention is to provide an adapter with a branch lumen that is arcuate and smoothly merges into the straight lumen of the adapter.
Another objective of the present invention is to provide a manufacturing process for producing the body portion of a Y-adapter that has an arcuate shaped branch lumen.
Still another objective of the present invention is to provide an adapter that has a unique hemo stasis seal at the proximal end of the main port and an arcuate port that smoothly merges into the main port.
These and other objects and advantages of the present invention will no doubt become apparent to those skilled in the art after having read the following detailed description of the preferred embodiment which are contained in and illustrated by the various drawing figures.